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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00393744 |
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Date of registration:
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27/10/2006 |
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Primary sponsor: |
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Public title:
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Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
PRI-angine |
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Scientific title:
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A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years. |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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395 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00393744 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Marie SEBILLE, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- subjects of both sexes
- aged between 6 and 25 years,
- weight : = 20kg
- with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or
tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable
satellite adenopathy)
- confirmation by positive RDT
- provision of throat swabs for culture
- ability to swallow tablets
Exclusion Criteria:
- Related to the study disease:
- suspected viral infection (concomitant dysphonia, cough, conjunctivitis,
rhinitis)
- adenophlegmon, peritonsillar abscesses.
- Related to the study treatment:
- known or suspected allergy to beta-lactamines (penicillin, cephalosporin)
- suspected infectious mononucleosis (increased risk of skin disorders)
- phenylketonuria (due to the presence of aspartame)
- congenital galactosaemia, glucose/galactose malabsorption syndrome, lactase
deficiency (due to the presence of lactose, in powder or suspension form)
- allergy to pristinamycin and/or virginiamycin
- history of pustular rash with pristinamycin
- hypersensitivity or gluten intolerant (due to the presence of wheat starch)
- ongoing treatment with cyclosporine, methotrexate, colchicine, allopurinol,
tacrolimus or oral anticoagulants.
- Related to previous treatment:
- subjects receiving antibiotic therapy in the month prior to inclusion, except
for azithromycin, for which the exclusion period is 3 months.
- subjects on short-term corticosteroids. Subjects on long-term corticosteroids
initiated before the start of the study and taken at a controlled dosage may be
included.
- Related to subjects:
- breast-feeding women
- women either pregnant or attempting to conceive
- subjects likely, during the course of the study to receive treatments prohibited
by the protocol
- treatment with other investigational drugs in the 4 weeks prior to inclusion in
the study
- immunodepression, clinically significant endocrine disease, cardiovascular
disease, neurological disease, or any other marked diseases resulting in
complications in performance of the study or interpretation of the study data
- known hepatic impairment
- known renal impairment (creatinine clearance < 30 ml/minute)
- cancer, blood dyscrasias
- previous history of drug or alcohol abuse.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
6 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tonsillitis
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Intervention(s)
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Drug: amoxicillin
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Drug: pristinamycin
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Primary Outcome(s)
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bacterial eradication
[Time Frame: at V3]
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Secondary Outcome(s)
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adverse events
[Time Frame: during the study]
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Secondary ID(s)
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EudraCT #: 2006-002127-16
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PRIST_L_01683
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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